Summary

Eligibility
for people ages up to 25 years (full criteria)
Location
at San Diego, California and other locations
Dates
study started
Principal Investigator
by Dimitrios Tzachanis
Headshot of Dimitrios Tzachanis
Dimitrios Tzachanis

Description

Summary

Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release.

Official Title

Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to Provide Access for Patients With Out of Specification Leukapheresis Product and/or Out of Specification Manufactured Tisagenlecleucel (CTL019; Kymriah®)

Details

The purpose of this Managed Access Program (MAP) Treatment Plan is to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

Keywords

Acute Lymphoblastic Leukemia (ALL) Diffuse Large B-cell Lymphoma (DLBCL) Acute Lymphoblastic Leukemia ALL Pediatric Diffuse Large b-cell Lymphoma DLBCL Adult Relapse Refractory CTL019 tisagenlecleucel Kymriah CART19 CART CAR T cells Chimeric antigen receptor Manufacturing Expanded Access Out of Specification Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse

Eligibility

You can join if…

Open to people ages up to 25 years

Patients eligible for inclusion in this Treatment Plan have to meet all of the following criteria:

  1. Patients must be treated at a healthcare facility that has been certified /qualified by Novartis to dispense and administer tisagenlecleucel in line with the tisagenlecleucel Risk Evaluation and Mitigation Strategy (REMS) in the United States (US) or the local Risk Management Plan (RMP).
  2. Note that tisagenlecleucel treatment should be initiated under the direction of and supervised by a HCP experienced in the treatment of hematological malignancies and trained for administration and management of patients treated with tisagenlecleucel. The healthcare facility must have tocilizumab for use in the event of cytokine release syndrome and emergency equipment per patient prior to infusion on site and ensure timely access to additional doses of tocilizumab; for detailed requirements refer to the approved local label.
  3. Patients must be prescribed tisagenlecleucel in line with the locally approved indications (for the precise indication statements see approved local product label).

These may include:

  • pediatric and young adult patients up to and (including) 25 years of age with refractory/relapsed (r/r) acute lymphoblastic leukemia (B-ALL)
  • adult patients with r/r diffuse large B-cell lymphoma (DLBCL)
  • Informed consent must be obtained prior to treatment
  • The incoming apheresis material and/or the final manufactured product is out of specification due to failure to meet acceptance or release specifications

You CAN'T join if...

Patients eligible for this Treatment Plan must not meet any of the following criteria:

  1. Contraindications as per the approved local label or the IB.

Locations

  • UC San Diego not accepting new patients
    San Diego California 92093-0979 United States
  • University of California at San Diego, Moores Cancer Ctr UCSD not accepting new patients
    San Diego California 92103 United States
  • Rady Children s Hospital Dept of Oncology not accepting new patients
    San Diego California 92123 United States
  • Rady Childrens Hospital not accepting new patients
    San Diego California 92123 United States

Lead Scientist at UCSD

  • Dimitrios Tzachanis
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 50 research publications

Details

Status
not accepting new patients
Start Date
Sponsor
Novartis Pharmaceuticals
ID
NCT03601442
Study Type
Expanded Access
Last Updated